"2023 is a pivotal year for Galera, as we received Priority Review designation for our NDA for avasopasem, and we look forward to continuing productive discussions with the FDA over the coming months," said Mel Sorensen, M.D., Galera’s President and CEO. "Avasopasem has the potential to be the first FDA-approved drug to reduce SOM, a debilitating radiotherapy-induced toxicity, in head and neck cancer patients undergoing standard-of-care treatment. Each year approximately 43,500 U.S. patients with HNC are at high risk of developing SOM as a result of their cancer treatment. Following our recent financing, we believe that we are well-equipped to build out our operations and expand our commercial leadership team in preparation for potential approval of avasopasem in the second half of the year."
Published first on TheFly
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